MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 840

Device Problems Occlusion Within Device (1423); Low Readings (2460)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported an 840 ventilator had a low oxygen percentage and a severe occlusion alarm.The non medtronic/covidien service provider confirmed the reported event.Service provider performed calibration and cleaned the expiratory filter.Both issues were corrected.Medtronic/covidien was not authorized to repair the device.

• Brand Name: 840 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer Contact: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6709237
• MDR Text Key: 79887714
• Report Number: 8020893-2017-06917
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521077133
• UDI-Public: 10884521077133
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K970460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 840
• Device Catalogue Number: 4-840220DIUA-EN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1